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Completed

NCT Number: NCT02533726

Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers

The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Health Care

Stanford, California, 94304, United States

About this study

This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices.

Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (>18 years of age)
  • Admission to Intensive Care Unit

Exclusion criteria

  • Children (<18 years of age)
  • Adhesive allergy
  • Physical limitation for sensor application

Treatment and study plan

Optimal Turning

Other

Patients within this arm will receive optimal turning practices. Nurses caring for these patients will receive real-time quantitative measures of patient turning procedures from the User Dashboard and provide a visual advisory to the nurse for the time to next turn.

Other names: Patient Turning, Pressure Ulcer Prevention

Standard Care Practices

Other

Patients within this arm will receive standard preventative care practices - that is, nurses will provide standard care as necessary, without the aid of visual advisories from a patient sensor.

Patient Sensor

Other

A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside.

Other names: Leaf Healthcare Patient Monitoring Sensor

Primary outcomes

  1. Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers

    Time frame: Duration of ICU admission (average 1 week)

    NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported.

    • Stage 1: Non-blanchable erythema of intact skin
    • Stage 2: Partial-thickness skin loss with exposed dermis
    • Stage 3: Full-thickness skin loss
    • Stage 4: Full-thickness skin and tissue loss
    • Unstageable: Obscured full-thickness skin and tissue loss
    • Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration

Secondary outcomes

  1. Compliance With Patient Turning Procedures

    Time frame: Duration of ICU admission (average 1 week)

    Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Leaf Healthcare, Inc.

Registry information

Official study title

Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers

Acronym: LS-HAPU

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 27, 2015
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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